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Intervention Study to Evaluate the Importance of Information Given to Patients With Contact Allergy (ISICA-13)

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ClinicalTrials.gov Identifier: NCT01953380
Recruitment Status : Completed
First Posted : October 1, 2013
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Andreas Sonesson, Region Skane

Brief Summary:
The purpose of this study is to determine whether extended information given to patients with contact allergy improves knowledge, treatment efficacy and daily functioning.

Condition or disease Intervention/treatment Phase
Dermatitis, Allergic Contact Behavioral: extended information Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intervention Study to Evaluate the Importance of Information Given to Patients With Contact Allergy
Study Start Date : October 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: extended information
Extended information on specific allergy
Behavioral: extended information
No Intervention: Information according to clin. routine
Information according to clinical routine



Primary Outcome Measures :
  1. knowledge [ Time Frame: one year after inclusion ]
    knowledge about specific contact allergies and exposure, assessed by questionnaire, a modified version of Nordic Occupational Skin Questionnaire NOSQ-2002/Long, and patient records.


Secondary Outcome Measures :
  1. clinical improvement [ Time Frame: one year after inclusion ]
    assessed by questionnaire, a modified version of Nordic Occupational Skin Questionnaire NOSQ-2002/Long, and patient records.

  2. quality of life [ Time Frame: one year after inclusion ]
    assessed by questionnaire, Dermatology Life Quality Index (DLQI).

  3. effect on daily functioning [ Time Frame: one year after inclusion ]
    assessed by questionnaire, a modified version of Nordic Occupational Skin Questionnaire NOSQ-2002/Long, and Dermatology Life Quality Index (DLQI).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with suspected contact allergy
  • Age above 18 years
  • Participants have given informed consent

Exclusion Criteria:

  • Mental or language disabilities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01953380


Locations
Sweden
Hudmottagningen SUS
Lund, Skåne, Sweden, 22185
Sponsors and Collaborators
Region Skane
Investigators
Principal Investigator: Andreas Sonesson, MD PhD Region Skåne, Hudkliniken SUS

Responsible Party: Andreas Sonesson, MD PhD, Region Skane
ClinicalTrials.gov Identifier: NCT01953380     History of Changes
Other Study ID Numbers: ISICA-13
First Posted: October 1, 2013    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017

Keywords provided by Andreas Sonesson, Region Skane:
Intervention Studies
Eczema
Randomized Controlled Trial
Knowledge
Quality of Life

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Allergic Contact
Skin Diseases
Dermatitis, Contact
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases